A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05508867
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • favezelimab/pembrolizumab — BIOLOGICAL
    Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
  • bendamustine — DRUG
    IV infusion
  • gemcitabine — DRUG
    IV infusion

Study Details

Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.

Key Dates

First listed
Aug 19, 2022
Start date
Oct 18, 2022
Status verified
Aug 2026
Primary completion
Sep 3, 2025
Completion
Jan 8, 2026

Study Design

Enrollment
203 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Favezelimab/Pembrolizumab
    Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.
  • Active Comparator: Chemotherapy (Bendamustine or Gemcitabine)
    Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.

Primary Outcome Measure

Progression Free Survival (PFS) Per Lugano Response Criteria as Assessed by Investigator [ Time Frame: Up to approximately 34 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer Center - North Campus ( Site 2216)TucsonArizona85719-
UCLA Hematology/Oncology - Santa Monica ( Site 2208)Los AngelesCalifornia90404-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( SiteTorranceCalifornia90502-
Moffitt Cancer Center ( Site 2200)TampaFlorida33612-
University of Kentucky Chandler Medical Center ( Site 2201)LexingtonKentucky40536-
Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)BaltimoreMaryland21231-
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)BaltimoreMaryland21201-
University of Michigan ( Site 2215)Ann ArborMichigan48109-
Cancer and Hematology Centers of Western Michigan ( Site 2222)Grand RapidsMichigan49503-
Rutgers Cancer Institute of New Jersey ( Site 2217)New BrunswickNew Jersey08903-
Roswell Park Cancer Institute ( Site 2220)BuffaloNew York14263-
Cleveland Clinic-Taussig Cancer Center ( Site 2203)ClevelandOhio44195-
University Hospitals Cleveland Medical Center ( Site 2214)ClevelandOhio44106-
AHN West Penn Hospital ( Site 2213)PittsburghPennsylvania15224-
UPMC Hillman Cancer Center ( Site 2205)PittsburghPennsylvania15232-
Fred Hutchinson Cancer Center ( Site 2212)SeattleWashington98109-

Related coverage on Hipa.ai

Find similar trials in Tucson, AZ

By research site
The University of Arizona Cancer Center - North Campus· Tucson, AZUCLA Hematology/Oncology - Santa Monica· Los Angeles, CALundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site· Torrance, CAMoffitt Cancer Center· Tampa, FLUniversity of Kentucky Chandler Medical Center· Lexington, KYJohns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

Related Studies